Monday, September 24, 2007

Adverse Drug Events Increase: Do the Benefits Outweigh the Risks?

Imagine someone being prescribed a drug that was approved by the FDA and their doctor. They would hope that the drug would alleviate their illness in some form or fashion. However, contrary to what we may expect, certain prescription drugs may cause adverse events, such as hospitalization or even death. What is worse is that warning of these adverse events may not even be included with the prescription. One study recently concluded that there has been an increase in the number of reported deaths and injuries associated with drug therapy. As I researched this topic more I discovered two quite insightful blogs challenging the key findings of this study. The first post I examined was from Furious Seasons, written by Philip Dawdy, a skeptical journalist suffering from bipolar disorder. This post lays the blame on the FDA, doctors and the media for not doing anything to bring more light to the issue of adverse drug events. The second post comes from a blog titled Clinical Psychology and Psychiatry: a Closer Look. Here, the author, “an academic with a respectable amount of clinical experience,” explores how clinical trials do a poor job of reporting drug safety outcomes. My comments to both these blogs, which can be found below and by following the links above, mainly focus on how some people may negatively react as a result of this increase in reported adverse drug events.

“Worse Than Vioxx: Zyprexa, Risperdal, Clozaril, And Paxil Killed Thousands of Americans” comment:
I agree with a lot of what you had to say on this topic. The media should really step it up and bring more light to such issues on reported adverse events. This, in turn, would increase public awareness. However, I could not help but wonder if more media coverage on these drug related deaths would ultimately lead patients to experience feelings of betrayal and mistrust toward their health care providers. In other words, patients being handed prescriptions will no longer trust the doctors issuing them. This might even cause them to avoid seeking treatment for their illness or deny drug therapy altogether. It hurt me most to hear that “Risperdal, a drug associated with over 1,000 deaths, is used in children--and the FDA approved its use”. How can drugs such as this one (see image above), used to treat schizophrenia, continue to be prescribed? It might be true that this drug has helped many. But, the FDA has to ask itself the pressing question: do the benefits outweigh the serious risks. I believe that risks such as death and disability outweigh the benefits. More research needs to be conducted on these drugs, in order to properly label all the side effects and to determine whether it is best to simply take the drugs off the market as was the case with Vioxx.

“The Drug Safety Blindfold” comment:
When I first read this study, one of the things that immediately caught my attention was the limitation that states that the submission of an adverse event does not establish causality. An adverse drug event could be reported by anyone who felt that there was a relationship between their drug and their adverse event. Right away this signaled to me that more research is needed to be sure that these adverse events are in fact being caused by the prescription drugs. I quickly visited the FDA MedWatch website and noticed how easy it was to submit a report. The reporting system should be altered, so that opinions from second sources such as health care providers can confirm suspected relationship with the drug. I agreed with Furious Seasons’ post that the media and the FDA need to further inform the public about the serious risks their prescription drugs may elicit, but I also feel that it is essential that more research be conducted first. Bringing too much attention to these pre-mature findings could lead many people to feel trepidation when taking their drugs or may lead them to report more and more serious injuries that may not even be related to the drug effects.


rkc said...

This topic that you chose to write on is a highly controversial topic that most definitely has two sides to it. I feel that you do a good job of addressing both aspects of this issue. Your comment on the Furious Seasons blog post was well-written and definitely challenged the position of the author. I do agree with you on the fact that these adverse events should be brought to light by the media, but I think that it may be a bit far-fetched to say that it would lead to patients distrusting their health care providers. It may lead to people questioning the drugs themselves and if they should take them, so maybe be careful not to draw such drastic conclusions. Also, in that comment you include a link that describes the drug Risperdal. It was a good idea for you to include a link to give the reader more information on the drug, however, Wikipedia is not an academic source, and should not be used other than for your personal research to better understand a topic.
Your second post on the blog Clinical Psychology and Psychiatry: A Closer Look did a good job of addressing the issue and the fact that we should not jump to conclusions about the causality of drug adverse effects. I liked how you mentioned the fact that you went and researched the way to submit a report. Maybe that is something that you could have included a link for in your blog to the site you looked at. Also, I would not talk about the other blog post, Furious Seasons, because the writer of this second blog may not understand what you are talking about. It works on your blog, because we can see your other comment, but on this second blog your first comment is not there to reference.
Overall, your post this week was well done. In your opening paragraph I like how you set up the fact that the blogs you addressed were from scholarly sources. However, the comment about them receiving the Thinking Blogger Award does not really mean anything to me because I do not know what it is for. If you could explain and let the reader know how they receive those awards that would be great. Also, when you are talking about the authors, maybe you could include a link to the authors’ biographies, because I assume that is where you got the quote about him being an “academic.” However, this was overall a thought-provoking post.

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